Reducing avoidable harms; Why is a Class IIa mattress the low-risk option for providers and patients?
Avoidable harms affect millions of lives around the world every year and cost billions of pounds to treat, therefore delivering harm free care to every patient is a priority for all healthcare providers.
Talley Group provide class leading products and services to improve patient outcomes and reduce the risk of avoidable-harms such as pressure ulcers, DVT, patient falls and infections.
As a recognised avoidable harm, pressure ulcers represent a key quality indicator for every healthcare provider. With eliminating avoidable pressure ulcers a clear goal for all healthcare professionals it is essential that each patient is provided with a safe support surface which meets their clinical needs.
A safe, effective, active therapy support surface is often an essential part of a comprehensive care package, however, how do you know that the mattress your patients use is safe and performs to the required level?
Talley have voluntarily raised the bar by making all of their powered pressure area care (PAC) support surfaces Class IIa medical devices. Before Class IIa devices can be awarded a CE mark an independent Notified Body verifies all technical documentation and claims of device safety and performance.
Unfortunately this is not the case for every mattress. Some powered PAC mattresses are Class I medical devices and gaining a CE mark for Class I products is so simple that manufacturers can ‘self-certify’. In other words no documentation, product safety or performance claims are ever independently verified by a Notified Body before the product gets its CE mark.
Therefore if you use powered pressure area care mattresses for the prevention and management of pressure ulcers or you are involved in their procurement, prescribing, or general risk management you need to be aware of the different levels of regulation that apply to Class I and Class II devices.
Only by understanding the differences in regulation relating to Class I and Class II devices will you be able to make a truly informed decision about which products suit your needs and the needs of the patients from a device safety and performance perspective.
Talley Group Limited
Abbey Park Industrial Estate
Tel: 01794 503500